Lutonix 035
FDA premarket approval P130024/S042 · decided 2021-12-02
Approval details
- PMA number
- P130024
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lutonix 035
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2021-11-18
- Decision date
- 2021-12-02
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Removal of a process documentation step for the vacuum drying process when no deviations from process parameters are identified during the automated cycle, to reduce redundancy.
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